Rapportering af bivirkninger og uønskede haendelser i randomiserede kliniske forsøg

Research output: Contribution to journalJournal articleResearchpeer-review

Bianca Betina Hemmingsen, Lina Støy, Jørn Wetterslev, Lise Tarnow, Karin Ursula Friis Bach, Louise Lundby Christensen, Nader Salas, Christian Nyfeldt Gluud, Copenhagen Insulin Metformin Therapy Trial-Gruppen, Hans Jørgen Duckert Perrild, Thure Krarup, Louise Lundby Christensen, Henrik Vestergaard

"Good clinical practice" (GCP) is an international guideline on how to conduct clinical trials on medical products involving human participants. Danish statute follows the EU trial directive (2001/20/EF) including the GCP guidelines. This article summarises the practical implementation of reporting adverse events and adverse reactions to the Danish Medicines Agency and the regional ethics committee based on the protocol of the ongoing Copenhagen Insulin and Metformin Therapy (CIMT) trial.
Original languageDanish
JournalUgeskrift for Laeger
Volume172
Issue number35
Pages (from-to)2381-4
Number of pages4
ISSN0041-5782
Publication statusPublished - 30 Aug 2010

ID: 34162749